An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02335346
• Date of registration: 07/01/2015
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)
• Scientific title: An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Osteoarthritis and Knee Pain
• Date of first enrolment: January 2015
• Target sample size: 93
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02335346
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

(Consecutive Participants)

- Participants who have completed the 15-week treatment in the preceding study HMGX.

(New Participants)

- Participants with present osteoarthritis (OA) based on American College of
Rheumatology (ACR) classification of idiopathic OA of the knee.

- Have pain for =14 days of each month for 3 months prior to study entry.

- Have a score of =4 on the BPI average pain score at the start of the study.

(Consecutive and New Participants)

- Females of child-bearing potential must test negative (-) on a pregnancy test.

Exclusion Criteria:

(New Participants)

- Participants who have any previous diagnosis of psychosis, bipolar disorder, or
schizoaffective disorder.

- Participants who have major depressive disorder as determined using depression module
of the Mini-International Neuropsychiatric Interview (M.I.N.I.).

- Participants who have received intrarticular hyaluronate or steroids, joint lavage, or
other invasive therapies to the knee in the past 1 week.

- Participants who have had knee arthroscopy of the index knee within the past year or
joint replacement of the index knee or osteotomy at any time.

- Participants have a prior synovial fluid analysis showing a white blood cell (WBC)
=2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.

- Participants who have a history of having more than one medical allergy.

- Are non-ambulatory or require the use of crutches or a walker.

- Have frequent falls that could result in hospitalization or could compromise response
to treatment.

- Have a history of drug abuse or dependence within the past year, including alcohol and
excluding nicotine and caffeine.

- Have a positive urine drug screen for any substances of abuse or excluded medication.

- Have received administration of another investigational drug within the 30 days prior
to enrollment.

- Have had previous exposure to duloxetine or completed/withdrawn from any study
investigating duloxetine.

(Consecutive and New Participants)

- Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory,
or hematologic illness, peripheral vascular disease, or other medical condition or
neuropsychiatric conditions or clinically significant laboratory abnormalities or
electrocardiographic abnormalities.

- Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) higher than 100 international units per liter (IU/L) or total bilirubin higher
than 1.6 milligrams/deciliter (mg/dL).

- Participants having serum creatinine level higher than 2.0 mg/dL, or had renal
transplantation or receiving renal dialysis.

- Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid
arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and
Type 1 diabetes).

- Participants who have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,
history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.

- Participants who have end stage bone disease or surgery planned during the trial for
the index joint.

- Participants treated with a monoamine oxidase inhibitor (MAO) within 14 days prior to
baseline, or those with the potential need to use MAO inhibitor during the study or
within 5 days of discontinuation of investigational drug.

- Participants who answer 'yes' to any of the questions about active suicidal
ideation/intent/behaviors occurring within the past month (Columbia-Suicide Severity
Rating Scale, suicide ideation section-questions 4 and 5; suicidal behaviors section).

- Have a primary painful condition that may interfere with assessment of the index
joint, i.e., knee.

- Pregnant participants, female participants who wish to be pregnant during the clinical
study period, or participants who are breast-feeding; or male participants who wish
pregnancy of the partner.

- Participants who cannot use appropriate contraceptive method or do not want to use
that from the start of the study until one month after the end of administration of
the investigational drug.

- Considered as inappropriate participation to the study for any medical or other reason
by the investigator.



Age minimum: 40 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis of the Knee

Intervention(s)

Drug: Duloxetine

Primary Outcome(s)

Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) [Time Frame: Baseline through Week 53]

Secondary Outcome(s)

Patient Global Impression-Improvement (PGI-I) at 50 Weeks [Time Frame: Week 50]

Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50 [Time Frame: Baseline, Week 50]

Percentage of Participants With Fall Events From Fall Questionnaire [Time Frame: Baseline through Week 50]

Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36) [Time Frame: Baseline, Week 50]

Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score [Time Frame: Baseline, Week 50]

Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument [Time Frame: Baseline, Week 50]

Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score [Time Frame: Baseline, Week 50]

Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) [Time Frame: Baseline, Week 50]

Secondary ID(s)

15611

F1J-JE-HMHD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shionogi

Results

• Results available: Yes
• Date Posted: 07/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02335346